Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Official Title ICMJE

A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer.

Detailed Description

OBJECTIVES:

Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide.

Determine the pharmacokinetics and safety of this drug in these patients.

OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.

Other Name: 4-HPR

Study Arm (s)

Experimental: Fenretinide

Intervention: Drug: Fenretinide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

11

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Biopsy-proven recurrent squamous cell carcinoma of the head and neck

Stage 4 disease, either at initial presentation or at recurrence. Patients with metastatic disease at initial presentation must have received at least one prior course of cytotoxic chemotherapy.

Patients who present with metastatic disease should have received no more than one prior regimen of chemotherapy or biologic therapy to be eligible. Patients who initially received adjuvant or induction chemotherapy and then recurred may have received one additional cycle of chemotherapy or biologic therapy at the time of recurrence. Patients may have received any number of cycles of a particular regimen of chemotherapy.

Patients must have a life expectancy of at least 3 months

Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.

Women of childbearing potential must agree to utilize two methods of effective birth control, one barrier, one hormonal, or should abstain from sexual intercourse that could result in pregnancy. Contraceptive measures should be continued for at least one month after fenretinide administration has been discontinued.

It is recommended that male patients with female partners of childbearing potential use barrier contraception while on fenretinide.

Exclusion Criteria:

Pregnant women (women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment in the study); women who are currently breast-feeding.